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moose_ears

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Comment #33527688
It is true that prescription (Rx) and over the counter (OTC) devices have different requirements, particularly with respect to the instructions for use, and many companies choose t…

Wed, Nov 09, 2022, 5:03 AM UTC
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Comment #33527624
This topic is addressed by Grady Hannah, co-founder and CEO of NightWare, on the June 23 edition of the DTx podcast with Eugene Borukhovich. FDA posted a PDF summary of its decisio…

Wed, Nov 09, 2022, 4:49 AM UTC
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MedCon: Industry praises FDA’s digital health Pre-Cert pilot
Fri, May 06, 2022, 3:23 AM UTC
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Comment #23495956
Related: https://open.fda.gov/apis/device/covid19serology/

Fri, Jun 12, 2020, 4:14 AM UTC